MedStar Healthcare Delivery Research Network MedStar Health Research Institute Washington DC USA.
Department of Medicine Georgetown University Washington DC USA.
J Am Heart Assoc. 2024 Jan 2;13(1):e032413. doi: 10.1161/JAHA.123.032413. Epub 2023 Dec 29.
In 3146 REDUCE-IT USA (Reduction of Cardiovascular Events With Icosapent Ethyl Intervention Trial USA) participants, icosapent ethyl (IPE) reduced first and total cardiovascular events by 31% and 36%, respectively, over 4.9 years of follow-up.
We used participant-level data from REDUCE-IT USA, 2021 US costs, and IPE costs ranging from $4.59 to $11.48 per day, allowing us to examine a range of possible medication costs. The in-trial analysis was participant-level, whereas the lifetime analysis used a Markov model. Both analyses considered value from a US health sector perspective. The incremental cost-effectiveness ratio (incremental costs divided by incremental quality-adjusted life-years) of IPE compared with standard care (SC) was the primary outcome measure. There was incremental gain in quality-adjusted life-years with IPE compared with SC using in-trial (3.28 versus 3.13) and lifetime (10.36 versus 9.83) horizons. Using an IPE cost of $4.59 per day, health care costs were lower with IPE compared with SC for both in-trial ($29 420 versus $30 947) and lifetime ($216 243 versus $219 212) analyses. IPE versus SC was a dominant strategy in trial and over the lifetime, with 99.7% lifetime probability of an incremental cost-effectiveness ratio <$50 000 per quality-adjusted life-year gained. At a medication cost of $11.48 per day, the cost per quality-adjusted life-year gained was $36 208 in trial and $9582 over the lifetime.
In this analysis, at $4.59 per day, IPE offers better outcomes than SC at lower costs in trial and over a lifetime and is cost-effective at $11.48 per day for conventional willingness-to-pay thresholds. Treatment with IPE should be strongly considered in US patients like those enrolled in REDUCE-IT USA.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01492361.
在 3146 名 REDUCE-IT USA（美国降低心血管事件用依泽替米贝干预试验）参与者中，依泽替米贝（IPE）在 4.9 年的随访中分别降低了 31%和 36%的首次和总心血管事件。
我们使用了来自 REDUCE-IT USA 的参与者水平数据、2021 年美国成本以及 IPE 每天 4.59 美元至 11.48 美元的成本，从而可以检查一系列可能的药物成本。临床试验分析是基于参与者水平的，而终生分析则使用了 Markov 模型。这两种分析都从美国卫生部门的角度考虑了价值。IPE 与标准治疗（SC）相比的增量成本效益比（增量成本除以增量质量调整生命年）是主要的结果衡量指标。与 SC 相比，IPE 在临床试验（3.28 比 3.13）和终生（10.36 比 9.83）范围内均有质量调整生命年的增量收益。使用每天 4.59 美元的 IPE 成本，与 SC 相比，IPE 在临床试验（29420 美元比 30947 美元）和终生（216243 美元比 219212 美元）分析中均降低了医疗保健成本。IPE 与 SC 相比是一种占主导地位的策略，在试验和终生内，获得的每增加一个质量调整生命年的增量成本效益比有 99.7%的可能性低于 50000 美元。在药物成本为每天 11.48 美元的情况下，获得的每个质量调整生命年的成本为试验中的 36208 美元，终生中的 9582 美元。
在这项分析中，以每天 4.59 美元的价格，IPE 在试验和终生内提供了比 SC 更好的结果，成本更低，并且在每天 11.48 美元的传统意愿支付阈值下具有成本效益。在美国的 REDUCE-IT USA 参与者中，应强烈考虑使用 IPE 进行治疗。
